Cleared Traditional

K963369 - BIO-ANCHOR

K963369 is the FDA 510(k) clearance for BIO-ANCHOR by Linvatec Corp.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K963369 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
268d
Days
Class 2
Risk

K963369 is an FDA 510(k) clearance for the BIO-ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 268 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Linvatec Corp. devices

Submission Details

510(k) Number K963369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1996
Decision Date May 22, 1997
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 158
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K963369.
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
K971358 · Arthrex, Inc. · Jul 1997
BIO-ANCHOR
K964805 · Linvatec Corp. · Jun 1997
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
K970896 · Ethicon, Inc. · Jun 1997
DEPUY DUPONT PHANTOM SUTURE ANCHOR
K964521 · Depuy, Inc. · Feb 1997
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K961789 · Zimmer, Inc. · Aug 1996
BIO-ANCHOR
K955486 · Linvatec Corp. · Feb 1996